Application 080408

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREELIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION1%NoNo
002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREELIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION1.5%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982
A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREELIDOCAINE HYDROCHLORIDE1.5%INJECTABLE / INJECTIONAPApproved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A080408-001AP
A080408-002AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-03-09 01:35 UTC2022-03A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 198287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19825aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19828869cabd3fbd…
2020-12-22 03:56 UTC2020-12A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982c0c555d07b60…
2020-11-12 02:37 UTC2020-11A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19821c564ffb4f44…
2024-02-18 07:12 UTC2024-02A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19829b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19823f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982053a50430f4f…
2023-05-13 08:27 UTC2023-05A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19823bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19823a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 1982f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A080408-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A080408-002AP184e616aacf4f…
2026-08-18 06:07:402026-07A080408-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A080408-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A080408-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A080408-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080408-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080408-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A080408-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A080408-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080408-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080408-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080408-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080408-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080408-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080408-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080408-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080408-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080408-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080408-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080408-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080408-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080408-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A080408-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080408-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080408-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080408-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080408-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080408-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080408-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080408-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A080408-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080408-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080408-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080408-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A080408-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080408-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A080408-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080408-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A080408-002AP174a2ff9319b5…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.3b2dd84e-cee8-4e58-d494-395a65a353a02026-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080408
application number: ANDA080408
ndc (product): 0409-4713
ndc (product): 0409-4776
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUSHenry Schein, Inc.a5d4b206-cc53-470f-9bca-abfc6ea5cc992025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080408
application number: ANDA080408
ndc (product): 0404-9887
LIDOCAINE HClLIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirste39435a3-1f69-78c5-e053-2995a90a7fc32024-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080408
application number: ANDA080408
ndc (product): 51662-1593
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.deec52c7-ebcf-422e-beab-bc1df2fe30cb2022-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080408
application number: ANDA080408
ndc (product): 76420-084

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9887Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousHenry Schein, Inc.ANDACurrent
0404-9887Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousHenry Schein, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
51662-1593LIDOCAINE HClLIDOCAINE HClHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-713Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousGeneral Injectables & Vaccines, IncANDACurrent
52584-713Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousGeneral Injectables & Vaccines, IncANDACurrent
52584-713Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousGeneral Injectables & Vaccines, IncANDACurrent
52584-713Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousGeneral Injectables & Vaccines, IncANDACurrent
52584-713Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousGeneral Injectables & Vaccines, IncANDACurrent
53225-3800ReadySharp LidocaineLIDOCAINE HYDROCHLORIDETerrain PharmaceuticalsANDACurrent
53225-3800ReadySharp LidocaineLIDOCAINE HYDROCHLORIDETerrain PharmaceuticalsANDACurrent
53225-3800ReadySharp LidocaineLIDOCAINE HYDROCHLORIDETerrain PharmaceuticalsANDACurrent
53225-3800ReadySharp LidocaineLIDOCAINE HYDROCHLORIDETerrain PharmaceuticalsANDACurrent
55154-3187Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUSCardinal HealthANDACurrent
55154-3187Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUSCardinal HealthANDACurrent
76420-084Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.ANDACurrent
76420-084Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.ANDACurrent